Catalog Number

-

Brand Name

Medical Action Industries

Version/Model Number

81737

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

MCY

Product Code Name

Wound dressing kit

Public Device Record Key

cdecf671-cf19-4629-aa8c-3c5b82a15971

Public Version Date

May 14, 2021

Public Version Number

1

DI Record Publish Date

May 06, 2021

Package DI Number

20809160350086

Quantity per Package

8

Contains DI Package

10809160350089

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-